Monographs for ginkgo raw materials (leaf and extract) can be found in various pharmacopoeias, including the United States Pharmacopoeia-National Formulary (USP-NF
) (United States Pharmacopeial Convention, 2013), the European Pharmacopoeia (EP) and the British Pharmacopoeia (BP) (British Pharmacopoeia Commission, 2012).
For context, standards apply to articles recognized in USP-NF
, and are conveyed in monographs, applicable general chapters, and General Notices.
General chapters published in the United States Pharmacopeia National Formulary (USP-NF
) outline information and testing procedures that apply across multiple products or groups of products and are often utilized early in the product development phase.
This edition of the USP-NF
contains several new features and revisions, including six new general chapters that will affect practices for both pharmacists and pharmaceutical manufacturers.
While some manufacturers choose to develop their own private testing methods and acceptance criteria (and thereby take the responsibility of demonstrating that their methods are scientifically valid), public standards such as The United States Pharmacopeia and The National Formulary (USP-NF
) offer a standardized method developed by experts in the field.
It needs to go beyond developing new General Chapters for USP-NF
. USP needs to lead discussions on biologies and biosimilars; USP needs to think about modernization in terms of complete systems and implementation of quality-by-design (QBD) in addition to individual standards; USP needs to incorporate safety concepts into its discussions about food ingredients and dietary supplements.
PF Online provides the same important preview of proposed changes to the United States Pharmacopeia and National Formulary (USP-NF
), as the print PF edition.
ProTab Laboratories has been certified through a 3Td-Party auditing firm validating that all Good Manufacturing Practices (cGMP-21CFR1I) established at ProTab Laboratories meet with all of the quality standards for Nutritional Supplements ANSI 173, USP-NF
. ProTab Laboratories uses strict quality control protocols and established Standard Operating.
drug standards are recognized in law in the United States; any medicine or ingredient marketed in the country must comply with applicable USP standards called out in federal law.
* USP Glossary: provides the meaning of technical terms relevant to the use of the USP-NF
USP's standards for pharmaceuticals are contained in the United States Pharmacopeia and the National Formulary (USP-NF
), which are recognized in U.S.
In addition to setting quality specifications for individual drug products and ingredients, USP sets practice/patient safety standards (contained in general chapters in our USP-NF